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NCT Number: NCT01783184

Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms

The Vascutek Anaconda™ Stent Graft System for repair of Abdominal Aortic Aneurysms (AAA) is the subject of this observational study. 180 patients will be implanted with the Anaconda™ Stent Graft System and will be followed-up annually for 5 years post-implant. The study will satisfy the requirements of the French National Authority for Health (Haute Autorité de santé) and the data collected will be used for reimbursement renewal.

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Casamance, Aubagne, France

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About this study

Infrarenal abdominal aortic aneurysms may be treated with the introduction of an abdominal aortic stent graft via the femoral route. This technique is commonly used in high surgical risk patients but can also be suitable under certain conditions for normal risk patients.

Abdominal aortic stent grafts, inserted via the femoral artery, are used to treat infrarenal abdominal aortic aneurysms, removing the need for an invasive surgical procedure.

The aim of this observational study is to evaluate the long-term (5 year) benefits of the technique by documenting the overall mortality, complications (endoleak, migration), rate of surgical conversion, progression and rupture of the aneurysm in a cohort of patients who are representative of the treated population under real conditions of use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patient implanted with the Vascutek Anaconda™ Stent Graft System for the treatment of a non-ruptured infrarenal Abdominal Aortic Aneurysm (AAA)

Exclusion criteria

  • Patients for whom clinical follow-up is impossible and cannot return for check-up visits

Treatment and study plan

Primary outcomes

  1. Overall mortality rate

    Time frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years

  2. Mortality rate related to rupture of the aneurysm and relationship to the stent

    Time frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years

  3. Change in diameter of the aneurysm

    Time frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years

  4. Rate of Type I, II and III endoleaks

    Time frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years

  5. Surgical conversion rate

    Time frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years

  6. Rate of endovascular or surgical revisions

    Time frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years

Sponsors and collaborators

Lead sponsor

Vascutek Ltd.

Industry

Registry information

Official study title

Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdo Minal Aortic Aneurysms

Important dates

Study start
2012
Primary completion
2013
Study completion
2019
First posted
Feb 4, 2013
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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